Open-label Brexpiprazole fMRI Trial in Adults With Major Depressive Disorder and Anxiety

A Phase 4, Multicenter, Single-arm, Open-label, Interventional fMRI Trial to Assess the Effect of Brexpiprazole as Adjunctive Therapy on Functional Brain Network Organization in Adults With Major Depressive Disorder and Symptoms of Anxiety

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05504486

Enrollment

Registered

2022-08-17

Start date

2022-08-29

Completion date

2023-04-05

Last updated

2023-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder (MDD)

Keywords

Major depressive disorder (MDD), symptoms of anxiety, fMRI, brain networks, modularity, community structure, brexpiprazole, default mode network, salience network, central executive network, functional brain connectivity

Brief summary

The purpose of this study is to use fMRI to evaluate the effects of brexpiprazole as add-on therapy to antidepressants on brain connectivity in individuals with MDD and symptoms of anxiety, aged 18 to 65.

Interventions

DRUGBrexpiprazole

Oral tablet; take once daily; target daily dose of 2 mg

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* 18 to 65 year of age * Major Depressive Disorder (MDD) with symptoms of anxiety * Stable treatment with less than 50% improvement

Exclusion criteria

* Contraindicated to perform fMRI scan * Previous exposure to brexpiprazole

Design outcomes

Primary

Measure	Time frame
Change in fMRI resting-state salience network community structure from baseline to post-treatment	Week 6

Secondary

Measure	Time frame	Description
Association between change in resting-state salience network community structure and change in MADRS total score from baseline to post treatment.	Week 6	Utilizing Jaccardized Czekanowski index
Change in Default Mode Network (DMN) community structure during emotional face viewing from baseline to post-treatment.	Week 6	Utilizing Jaccardized Czekanowski index
Change in Central Executive Network (CEN) community structure during a working memory task from baseline to post-treatment.	Week 6	Utilizing Jaccardized Czekanowski index

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026